Ecological Momentary Assessment (EMA) refers to the collection of repeated measurements of phenomena as they occur in naturalistic settings using hand-held computers. By providing an EMA of psychosocial variables that influence patient pain and pain behaviors, this study seeks to characterize the pain experience in metastatic breast cancer from both patients' and spouses' perspectives.

This study consists of two parts. Part 1 involves developing and pilot testing a hand-held computer program designed to assess antecedents, behaviors, and consequences of patient pain, as well as spouse response to pain. Five couples will complete a baseline survey and carry the hand-held computer for two weeks. They will be interviewed for feedback to refine the program. Part 2 is a longitudinal assessment of the psychological and relationship functioning of metastatic breast cancer patients and their spouses. The Optional Procedure for Part 2 involves using electronic diaries (EDs) to measure the cancer pain experience for patients with metastatic breast cancer and their spouses.

The specific aims of this study are to: (1) To examine patient pain, spouse response to patient pain, and patient behaviors in response to pain over the course of 6 months in couples facing metastatic breast cancer, (2) test the biopsychosocial model of chronic pain in breast cancer; expanding it to include the influence of patient psychological functioning, spouse psychological functioning, and relationship functioning, on patient pain, spouse behaviors, and patient behaviors in response to pain, (3) use ecological momentary assessment to characterize patient pain, spouse response to patient pain, and patient behaviors in response to pain.

Women diagnosed with metastatic breast cancer and their male spouse or significant other

Criteria

Inclusion Criteria:

For Patients: Being a female patient diagnosed with metastatic breast cancer.

For Patients: Initiating treatment for metastatic breast cancer

For Patients: Having and ECOG Performance Status Score of 2 or less

For Spouses: Being the male spouse or significant other of a female patient diagnosed with metastatic breast cancer

For Spouses: Having the patient's consent to be contacted

For Patients and Spouses: Having the ability to read and speak English well enough to understand the consent form and complete the questionnaires

For Patients and Spouses: Being able to provide informed consent

Exclusion Criteria:

For Patients and Spouses: Not being able to provide informed consent.

For Patients: Rating average pain as 0 on the BPI

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386620